NCT04629547 · Washington University School of Medicine
Sleep Trial to Prevent Alzheimer's Disease
(SToP-AD)
What this study is about
The purpose of this study is to determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain.
View original scientific description
The purpose of this study is to determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain.
Interventions
DRUG
Suvorexant 20 mg
Suvorexant 20mg will be taken nightly for 24 months.
DRUG
Placebo
Placebo will be taken nightly for 24 months.
Primary outcome measures
Change from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo
Time frame: 18-24 months
Blood collection
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female.
- Any race or ethnicity.
- Participants must be age ≥65 years and able to sign informed consent.
- Global Clinical Dementia Rating (CDR) 0.
- Willing and able to undergo study procedures.
Exclusion criteria
- History of reported symptoms suggestive of restless legs syndrome, narcolepsy or other central disorder of hypersomnolence, or parasomnia
- STOP-Bang score \>6 for participants without PAP
- Untreated OSA with AHI ≥15 on home sleep test
- Treated sleep apnea with PAP non-compliance
- PAP compliance is defined as \>= 4 hours per night \>70% of the nights
- Plasma A-beta and tau test with a plasma p-tau 217% ≤ 1.19
- Chronic kidney disease defined as patients with markers of kidney damage or eGFR of \< 45 ml/min/1.73m2.
- Hepatic impairment defined as AST and/or ALT \> 2x upper limit of normal (normal limits AST: 11-47 IU/L, ALT: 6-53 IU/L).
- History of substance abuse or alcohol abuse in the proceeding 6 months.
- Regular alcohol consumption 3 or more days a week over the last 6 months. Regular alcohol consumption is defined as having more than 2 alcoholic beverages within 3 hours of bedtime. Participants that agree to reduce alcohol consumption during the study may not be excluded.
- History of presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or participant report that could affect the safety of the participant or interfere with study assessments or in the judgement of the Principal-Investigator (PI) if participant is not a good candidate.
- Has any medical condition that, in the PI's opinion, could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data. Potential medical conditions that will be exclusionary at the PI's discretion:
- Cardiovascular disease requiring medication except for controlled hypertension.
- Pulmonary disease.
- Type I diabetes.
- Neurologic or psychiatric disorder requiring medication.
- Tobacco use.
- Use of sedating medications.
- Use of medications that interact with suvorexant (if cannot be discontinued)
- Abnormal safety labs
- History of current suicidal ideations.
- Currently pregnant or breast-feeding.
- In the opinion of the PI, the participant should be excluded due to an abnormal physical examination.
- Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment.
- Must not participate in another drug or device study prior to the end of this study participation. Exclusion criteria for optional lumbar punctures -• Contraindication to lumbar puncture (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery).
Where
- St Louis, Missouri
Collaborators
Good Ventures, Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations